Software in Medical Devices, by MD101 Consulting

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IEC/FDIS 62366-1 released in November 2014

The FDIS (final draft version) of IEC 62366-1 was released in November 2014. This version, also known as IEC 62366 2nd edition, is on the right track to be officially released in Q1 2015. It will supersede the IEC 62366:2007 + Amendment 1:2014.

Recognized and Harmonized

After its official publication by the IEC, this standard shall become first recognized or harmonized, to be implemented by medical device manufacturers. It should take some more time and we can bet that IEC 62366-1 won't be recognized or harmonized by the end of 2015 (but, huh, we never know).
However its content should be reviewed to assess the gap analysis with ergonomics studies of devices currently in design phase. If the placing on the market of such devices is not forecasted before the harmonization/recognition of the standard, then it should be questioned to realize ergonomic studies in compliance with this IEC 62366-1.

Changes in IEC 62366-1

Compared to IEC 62366:2007 + Amendment 1:2014, IEC 62366-1 usability engineering process was deeply reshaped.

Where are V&V?

Verification and validation have disappeared from this new version. They were replaced by the concept of user interface evaluation.
It is more in line with the concepts and methods that are familiar to ergonomic engineers.

User interface evaluation

Devil is in the details, the section 3.27, definition of User Interface Evaluation, contains a note which explains that User Interface Evaluation is part of medical device verification and validation activities. Here we are!
The note also explains that User Interface Evaluation is made of formative evaluation and summative evaluation, two steps in the usability engineering process.

Usability engineering process

As a consequence, the usability engineering process found in section 5 of the standard was totally reshaped.
It was also reshaped to be more in line with the requirements found in ISO 14971. The process now quotes the paragraphs of ISO 14971 (i.e. the steps of the risk management process) related to the steps of the usability engineering process.

Compliance with IEC 62366-1

Manufacturers claiming compliance with IEC 62366:2007 will have plenty of work ahead of them, to ensure compliance with IEC 62366-1.
The main problem will probably to find the right people, who are able to implement the process described in section 5 of the standard. These people will require to have at the same time knowledge about medical device risk management and usability engineering.
Whereas the current version of IEC 62366 leaves space for adapting (tweaking?) the ergonomic studies to design processes already in place in design teams, the new one imposes an obligation to have a formative evaluation and a summative evaluation.
No escape plan.

Next time, we'll see the consequence of this standard on software design process.


1. On Thursday, 5 March 2015, 17:53 by Claudia Bach

FYI: The new IEC 62366-1 2015 Edition 1.0 has just been released. It replaces IEC 62366. The part 2 (IEC 62366-2) is still in process and not yet available.
If you would like to read more about the new release, you are welcome to take a look at my review of the document at  

Claudia Bach
Document Center Inc.

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